Kornimate/medical-research-clean huggingface dataset:
effects of nateglinide on postprandial glucose excursion by restoring early phase insulin secretion

Conditions: Diabetes Mellitus, Type 2

Summary: a 3-week, multi-center, open-label, randomized, active-control, parallel-group study to compare effects of nateglinide and acarbose on postprandial glucose fluctuation in chinese drug-naive patients type 2 diabetes mellitus (t2dm). in this study, participants in different groups took nateglinide at a dose of 120 mg orally three times daily for up to 3 weeks or acarbose at a dose of 50 mg three times daily for up to 3 weeks, respectively.


Eligibility criteria:
inclusion criteria 1. patients must give written informed consent before any assessment is performed. 2. male, non-fertile female or female of childbearing potential using a medically approved birth control method based on local regulations. 3. drug naïve type 2 diabetes patients, defined as who neither take consecutive anti-hyperglycemic drug treatment more than 3 months anytime, nor any anti-hyperglycemic drug treatment in 4 weeks prior to visit 1. 4. age in the range of 18-75 years inclusive. 5. hba1c in the range of \> 6.5 to ≤9.0% at visit 1. exclusion criteria 1. pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test (\>5 miu/ml). 2. with known hypersensitivity to nateglinide, acarbose or any of the excipients. 3. a history of, 1. type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., cushing's syndrome and acromegaly. 2. acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months. 3. torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation. 4. percutaneous coronary intervention within the past 3 months. 5. any of the following within the past 6 months: myocardial infarction (mi), coronary artery bypass surgery, unstable angina, or stroke. 4. evidence of significant diabetic complications, e.g., symptomatic autonomic neuropathy or gastroparesis. 5. acute infections which may affect blood glucose control within 4 weeks prior to visit 1. 6. congestive heart failure requiring pharmacologic treatment. mg/dl (123μmol/l)

Keywords: diabetes mellitus, type 2 nateglinide acarbose glucose fluctuation
morphofunctional lung analysis by positron emission tomography

Conditions: Acute Lung Injury; Acute Respiratory Distress Syndrome

Summary: patients affected by acute lung injury-acute respiratory distress syndrome (ali-ards) undergo a positron emission tomography (pet) scan in order to analyse lung function.


Eligibility criteria:
inclusion criteria: * ali-ards * age \> 18yrs exclusion criteria: * copd

Keywords: ali/ards
statistical analysis of prevalence, incidence, comorbidities and medical expense in epileptic children in taiwan based on national health research insurance database.

Conditions: Neurologic Disorder; Seizure Disorder

Summary: epilepsy is a common disease in pediatric neurology. in recent years, due to the promotion of taiwan's health insurance and the advancement of related medical treatments and anti-epileptic drugs, the prevalence, incidence, and related comorbidities of childhood epilepsy in taiwan are expected, as well as the number of epilepsy patients in different regions or different age groups. and medical costs may change. this study aims to collect data from the national health insurance database through the national institutes of health, review relevant data on childhood epilepsy patients from 2001 to 2013, and analyze trends to discuss the impact of universal health insurance and medical progress on childhood epilepsy patients. impact.


Eligibility criteria:
inclusion criteria: 1. targets aged 0\~19 (\<=19) in the home country 2. diagnosis code includes icd9: 345.xx, acode:a225 (including outpatient and inpatient) 3. between 2001 and 2013, those who had seen a doctor three times in a row with epilepsy diagnosis codes and used anti-epileptic drugs exclusion criteria: * exclude those who sought medical treatment for epilepsy from 2001 to 2013, but the number of medical visits (outpatient + hospitalization) \<3 times, and exclude those who did not take medication from 2001 to 2013.
safety and efficacy study of contezolid acefosamil and contezolid compared to linezolid administered intravenously and orally to adults with moderate or severe diabetic foot infections (dfi)

Conditions: Diabetic Foot Infection

Summary: this is a phase 3, multicenter, randomized, double-blind, safety and efficacy study of contezolid acefosamil (iv)/contezolid (po) compared with linezolid (iv and po) administered for a total of 14 to 28 days in adult subjects with moderate or severe dfi.

approximately 865 subjects (519 contezolid acefosamil/contezolid: 346 linezolid) will be enrolled with moderate or severe dfi that are confirmed or suspected to be due to a gram-positive bacterial pathogen (mitt analysis set).

Eligibility criteria:
inclusion criteria: * have diabetes mellitus (type 1 or 2) per the american diabetes association criteria * have a foot infection that started at or below the malleolus and does not extend above the knee * foot infection that meets the iwgdf dfi criteria for classification 3 (moderate infection) or 4 (severe infection) * foot infection had acute onset or worsening of signs and symptoms within the past 14 days exclusion criteria: * previous dfi known or suspected to be caused by gram-positive pathogens that are resistant to oxazolidinone antibiotics * dfi with presumptive evidence or suspicion of osteomyelitis * necrotizing fasciitis, crepitant cellulitis, wet gangrene, gas gangrene, ecthyma gangrenosum, septic arthritis, or severely impaired arterial supply to any portion of the affected foot which may need revascularization before the end of the study * evidence of significant hepatic, renal, hematologic, or immunologic disease * females who are pregnant or breastfeeding * prior receipt of any formulation of contezolid acefosamil or contezolid * inability to cooperate fully with the requirements of the study protocol, including the schedule of events, or likely to be noncompliant with any study requirements, or the investigator determines that the subject should not participate in the study
infusional c-myb asodn in advanced hematologic malignancies

Conditions: Hematologic Malignancies

Summary: the purpose of this study is to evaluate whether c-myb antisense (as) oligonucleotides (odns)is a possible treatment modality for advanced hematologic malignancies.


Eligibility criteria:
inclusion criteria: * patients must have one of the following: acute myeloid or lymphoid leukemia; or myeloproliferative disorder(mpd) including chronic myelogenous leukemia (cml); or myelodysplastic syndrome (mds); or non-hodgkin's lymphoma (including cll); or multiple myeloma * patients with acute leukemia must meet one of the following conditions: \*have disease which is refractory to a course of standard induction chemotherapy \*have relapsed diseased after documentation of previous clinical remission or \*have untreated disease and not be a candidate for conventional first line treatment * patients with cml or other mpd must have evidence of accelerated phase or blast crisis * patients having clinical features of cml in transformation but who are negative for philadelphia chromosome may be entered provided there is a prior definable chronic phase * patients with philadelphia chromosome positive cml must have failed treated with gleevec (imatinib) in order to be eligible for study * patients with myelodysplastic syndrome (mds) must have \> 5% blasts in the peripheral blood or bone marrow and have at diagnosis as ipss score of \>= 1 * patients with cll must have relapsed or refractory disease after at least three courses of conventional therapy and have been determined to no longer be a candidate for conventional therapy * patients with non-hodgkin's lymphoma (other than cll) must have relapsed or refractory disease after at least two courses of chemotherapy and have been determined not to be a candidate for further conventional therapies * patients with multiple myeloma must have failed at least 3 prior therapies * performance status 0, 1 or 2 * serum creatinine \< 2.0 mg/dl; serum bilirubin \< 2 mg/dl and ast/alt \< 3.0 x upper limit of normal * ptt within normal range * age \> 18 * patients must have an indwelling central venous catheter exclusion criteria: * significant cardiac disease which requires active therapy * intercurrent organ damage or medical problems that will jeopardize outcome of therapy * pregnant or lactating females * received prior c-myb as odn therapy * patients with suitable hla identical sibling donor who are deemed to be appropriate and willing candidates for allogeneic bone marrow transplantation * patients requiring anticoagulation with unfractionated heparin.

Keywords: hematologic malignancies c-myb c-myb as odn
stratagraft® skin tissue as an alternative to autografting deep partial-thickness burns

Conditions: Skin Wound; Burns; Trauma-related Wound

Summary: the proposed study is designed as a phase ib open-label, dose-escalation, multicenter study evaluating the safety, tolerability, and efficacy of stratagraft skin tissue in promoting the healing of the deep partial-thickness component of complex skin defects. the proposed study population will include patients with 3-49% total body surface area (tbsa) complex skin defects including a deep partial-thickness component resulting from thermal injury. the study has been designed to focus on the evaluation of safety and tolerability of prolonged exposure to increasing amounts of a single application of stratagraft skin tissue, while also assessing the potential for stratagraft tissue to promote healing of the deep partial-thickness component of these complex skin defects as an alternative to donor site harvesting and autografting. targeted enrollment for this study is up to 30 patients with complex skin defects due to thermal burns which require surgical excision and autografting. subjects will be sequentially enrolled in two cohorts of increasing treatment area receiving stratagraft skin tissue that has been stored refrigerated prior to clinical use. a third cohort will receive stratagraft skin tissue which has been stored cryopreserved and thawed in the operating room just prior to grafting.


Eligibility criteria:
inclusion criteria: * men and women aged 18-65 years, inclusive * written informed consent * sufficient healthy skin identified and designated as a donor site in the event that the stratagraft treatment site requires autografting * complex skin defects of 3-49% tbsa requiring excision and autografting * total burn may consist of more than one wound area * deep partial-thickness thermal burn(s) with total area of 88 to 880 cm2 requiring excision and autografting * first excision and grafting of treatment sites exclusion criteria: * pregnant women and prisoners * patients receiving systemic immunosuppressive therapy * patients with a known history of malignancy * preadmission insulin-dependent diabetic patients * patients with concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives * expected survival of less than three months * participation in the treatment group of an interventional study within preceding 90 days prior to enrollment * full-thickness burns will be excluded as treatment sites * chronic wounds will be excluded as treatment sites * the face, head, neck, hands, feet, buttocks, and areas over joints will be excluded as treatment sites * treatment sites adjacent to unexcised eschar * clinical suspicion of burn wound infection at the anticipated treatment sites
cae for poorly adherent individuals with schizophrenia

Conditions: Schizophrenia

Summary: this project aims to evaluate the feasibility, acceptability and preliminary efficacy of remotely delivered cae among patients with schizophrenia (cae-s).

patients with schizophrenia will be randomly assigned to receive either cae-s or etau following the baseline assessment. the primary feasibility outcomes will be attendance and patient satisfaction (aim 1) and change from baseline to 12 weeks in schizophrenia symptoms as measured by the positive and negative symptom scale (panss) (aim 2). an exploratory evaluation (aim 3) will examine the posited mechanistic underpinnings of the cae-s intervention by assessing change from screening to 12 weeks in psychotropic medication adherence as measured by the tablets routine questionnaire (trq) and validated by ecap (objective bottle openings). secondary measures will include the clinical global impression (cgi), functional status, quality of life and attitudes towards medication.

Eligibility criteria:
inclusion criteria: * individuals age 18 and older with schizophrenia as confirmed by the mini international psychiatric inventory (mini) * prescribed an antipsychotic medication for treatment of schizophrenia * known to have medication treatment adherence problems as identified by the tablets routine questionnaire (trq, 20% or more missed medications in past week or past month) * ability to be rated on psychiatric rating scales * currently in treatment or scheduled to receive treatment at a community mental health clinic (cmhc) or other clinical setting able to provide mental health care during and after study participation * able to provide written, informed consent to study participation * has access to electronic device and internet to complete sessions conducted on videoconferencing platform exclusion criteria: * prior or current treatment with clozapine (clozapine therapy includes additional medication-related monitoring and clinical visits that may impact medication adherence) * medical condition or illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial * physical dependence on substances (alcohol or illicit drugs) likely to lead to withdrawal reaction during the course of the study in the clinical opinion of the treated research psychiatrist * immediate risk of harm to self or others * female who is currently pregnant or breastfeeding
clinical trial of the edwards aortic bioprosthesis, model 11000

Conditions: Aortic Valve Disorder; Aortic Valve Insufficiency; Aortic Valve Stenosis; Heart Failure; Coronary Artery Disease

Summary: the purpose of this observational trial is to gather further clinical data to confirm the safety and performance of the edwards pericardial aortic bioprosthesis, model 11000 in this trial population.

this is a prospective, non-randomized, non-controlled observational clinical trial. up to 200 subjects will be enrolled at up to 6 participating clinical sites. the trial will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic valve. patients will be followed and assessed after implant for up to 5 years.

Eligibility criteria:
inclusion criteria: * 18 years or older * require replacement of aortic valve * signed informed consent * willing to return to study site for follow-up visits exclusion criteria: * active endocarditis/myocarditis (\< 3 months) * myocardial infarction (\< 30 days) * renal insufficiency/ end-stage renal disease * life expectancy (\< 1 year) * requires multiple valve replacement/repair * requiring emergent aortic valve surgery * pregnant or lactating

Keywords: aortic valve replacement/regurgitation
impact of a transportable customizable and scalable sitting positioning device on swallowing disorders

Conditions: Deglutition Disorders

Summary: when the seat is a vehicle for disabled person, postural adaptation methodology is known and, on prescription, there is possibility of financial support for technical posture assists. for people who use a standard seat, a chair for example, there is no satisfactory existing hardware. a transportable customisable and scalable sitting positioning device (datp device), to be placed on a standard seat, is a solution that might fit in the home, in specialized foster homes or in institutions for the elderly. such a device has been developed but earnings on swallowing disorders have to be validated.


Eligibility criteria:
inclusion criteria : * present a swallowing disorder authenticated by a score dysphagia handicap index above 11 * postural disorder authenticated by a score greater than 0 to at least 1 of the following 3 items to mcpaa: retroversion, obliquity and rotation of the pelvis * autonomy conservation compatible with the use of different seats including standard seats * signing of informed consent exclusion criteria: * postural disorder requiring the use of only one type of installation (wheelchair or hull) * spinal stiffness or non-reducible hips (spondylitis, osteosynthesis rod) * not included anthropometric dimensions between: * basin with between 39 and 50 cm * femoral length between 42 and 52 cm * tibial length between 39 and 44 cm (46.5 with femoral recharge), measured with the shoes. * pregnant or lactating women

Keywords: medical device
long-term oral acyclovir usage to prevent herpes zoster virus infection after bone marrow transplant

Conditions: VZV Infection After Bone Marrow Transplantation

Summary: the objective of this study is to prevent reactivation of herpes zoster during the first year after transplant.

herpes zoster infection occurs in 30% of allogeneic hematopoietic cell transplant (hct) recipients who had a history of varicella zoster virus (vzv) infection. a safe and effective prevention strategy has not been established. 77 marrow allograft recipients at risk for vzv reactivation were randomized to oral acyclovir 800 mg twice daily or placebo given from day 30 until day 365 and were followed for toxicity and clinical evidence of herpes zoster infection.

Eligibility criteria:
inclusion criteria: * 10 years or older * both sex (male or female) * allogeneic transplant patient for hematologic malignancy or aplastic anemia exclusion criteria: * previous intolerance to acyclovir * patients who are unavailable for follow-up * patients in whom drug compliance may be a problem * evidence of active vzv infection * vzv infection in the initial 1 month after transplant * pregnant women, lactating women, or those not using adequate contraception * creatinine \> 3.0 mg/dl.

Keywords: varicella zoster virus infection vzv infection oral acyclovir allogeneic bone marrow transplantation allogeneic hematopoietic cell transplantation
a diagnostic test for dementia with lewy bodies

Conditions: MCI-AD, Early Stage Alzheimer's Disease; MCI-DLB, Early Stage Dementia With Lewy Bodies

Summary: the syn-d study will be evaluating α-synuclein in patients with suspected mci-ad and mci-dlb. using a simple diagnostic test will improve clinical accuracy in diagnosing, earlier diagnosis, and distinguish between neurodegenerative diseases.

in collaboration with approximately 10 centers that specialize in dlb and dementia we will recruit a total of 80 individuals for the study: 40 subjects with suspected mci-dlb and 40 with suspected mci-ad will be recruited. all subjects will be enrolled into a 12 month longitudinal study where skin biopsies will be performed at 3 sites on each patients at 12 month intervals (baseline and 1 year). detailed quantified examination, cognitive evaluation, history, and questionnaires will be performed at each visit and will be reviewed by a central panel of disease experts to confirm the diagnosis. subjects enrolled in the study will have baseline evaluations and follow up visits at 12 months to define any changes to clinical diagnosis. skin biopsies will be repeated at the 12 month follow up visit to determine the rate of p-syn accumulation over time and rates of nerve fiber degeneration within punch skin biopsies.

Eligibility criteria:
inclusion criteria: 1. men and women 50 to 85 years of age 2. clinical diagnosis of mild cognitive impairment, and a presumed etiology of dlb or ad at enrollment exclusion criteria: 1. clinical evidence of severe peripheral vascular disease (fazekas score of ≥ 3, or a large vessel stroke of ≥ 2 cm, history of ulceration, poor wound healing, vascular claudication) 2. clinically active coronary artery or cerebrovascular disease 3. current smoker or alcoholism 4. history of allergic reaction to local anesthesia (for biopsy collection) 5. use of anticoagulants (aspirin or plavix alone is allowed) 6. significantly impaired wound healing or history of scarring or keloid formation
pharmacokinetic study of paracetamol uniflash (125 mg/1.25 ml)

Conditions: Acute Pain

Summary: this study aims to assess the pharmacokinetic profile of a new paracetamol formulation (paracetamol uniflash 125mg/1.25ml) for buccal use after single dose.


Eligibility criteria:
inclusion criteria: * male and non-pregnant female human subjects, age 18 - 45 years. * body mass index between 18.5-30 kg / m2 . * subjects with normal findings . * willingness to follow the protocol requirements exclusion criteria: * history of allergy or hypersensitivity intolerance to paracetamol and ethanol * significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, dermatological, immunological or psychiatric diseases, or organ dysfunction; * lactating or nursing female subjects; * history of difficulty in accessibility of veins in arms.
neonatal bacterial meningitis cohort

Conditions: Bacterial Meningitis; Neonatal Infection

Summary: neonatal bacterial meningitis (bm) is a devastating infection that occurs more commonly in neonates than in any other age group, and is associated with significant morbidity and mortality, especially in developing countries. in this study, we aimed to develop a clinical risk score model, according to the available clinical syndromes and commonly laboratory tests, for screening bm among full-term neonates in a large-scale retrospective cohort, and prospectively validated the risk score in multicenter cohort.

in this study, we aimed to develop a clinical risk score model, according to the available clinical syndromes and commonly laboratory tests, for screening bm among full-term neonates in a large-scale retrospective cohort, and prospectively validated the risk score in multicenter cohort.

Eligibility criteria:
inclusion criteria: * subject has a positive cerebrospinal fluid culture of bacterial pathogen(s) * subject has a positive blood culture of bacterial pathogen and counts of white blood cells in cerebrospinal fluid ≥ 20×106/l * subject has counts of white blood cells in cerebrospinal fluid ≥ 20×106/l and counts of neutrophils ≥ 10×106/l as well as suspected clinical symptoms exclusion criteria: * history of brain trauma, brain tumor, cerebral palsy, epilepsy, and ventricular shunt device * history of accepting neurosurgery * subject has missing data